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U.S. Food and Drug Administration (FDA or the Agency) announced the availability of two draft guidance documents in the Federal Register: “General Wellness: Policy for Low Risk Devices” (General Wellness Guidance) and “Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types” (Accessories Guidance).

01/22/15
Beyond the FCC: How Other Agencies are Grappling with Communications and Related Issues, presented for a FCBA Young Lawyers Committee Brown Bag Lunch, Washington, D.C.

Jonathan A. Havens

Associate

Jonathan A. Havens is an associate in Morgan Lewis's FDA Practice.His practice focuses on FDA and healthcare regulatory, compliance, enforcement, and transactional issues. In this capacity, Mr. Havens represents clients in matters relating to medical devices, prescription and non-prescription pharmaceuticals, foods, food additives, dietary supplements, tobacco products, including e-cigarettes, and cosmetics, as well as marketing, promotion, and advertisement. He assists clients in various matters related to state regulatory requirements, including state licensing requirements, for healthcare providers and pharmacies, as well as drug and device manufacturers and distributors.

Mr. Havens advises clients on regulatory and compliance matters of the Consumer Product Safety Commission, the Drug Enforcement Administration, the Department of Veterans Affairs, the Small Business Administration, and Customs and Border Protection. His experience includes representing clients before the Food and Drug Administration, the Department of Health and Human Services, and the Consumer Product Safety Commission.

Prior to joining Morgan Lewis, Mr. Havens was a regulatory counsel with the U.S. Food and Drug Administration. While at the FDA, Mr. Havens received an FDA Group Recognition Award for Compliance and Enforcement of Tobacco Product Regulations and a Center for Tobacco Products Team Excellence Award. Before his legal career, Mr. Havens was a legislative aide in the U.S. Senate and U.S. House of Representatives, as well as a legislative specialist with a national law firm.

Mr. Havens's recent representative client matters include:

Represented a multinational food processor and marketer in defeating a federal government contract bid protest

Represented a multinational pharmaceutical company in its successful request for orphan drug designation

Represented a medical device company in a pair of successful applications for marketing clearance

Represented a mail order pharmacy in its sale of stock to a pair of private equity groups

Mr. Havens maintains an active pro bono practice, and has represented clients before the D.C. Superior Court, the Social Security Administration, and the Centers for Medicare and Medicaid Services and related state agencies. He serves on Morgan Lewis's Washington, D.C. office Pro Bono Committee and is a member of the Office Relations Committee.

Beyond his representational experience, Mr. Havens has written and spoken about federal and state health industry transparency requirements, and he is member of the Morgan Lewis Health Industry Transparency Compliance Team. He has also written about food product label claims, tobacco products, including e-cigarettes, mobile medical applications, food safety, and pharmacy billing practices.

Mr. Havens earned his J.D. from the Catholic University of America, Columbus School of Law in 2010, where he was an associate editor for the Catholic University Law Review. He earned his B.A. in American politics from the University of Virginia in 2005, where he graduated on the Dean's List.

Mr. Havens is admitted to practice in the District of Columbia, Virginia, and Florida.